Parker Bioscience Filtration, a division of Parker Hannifin, the global leader in motion and control technologies, announced the launch of SciLog® NFF+ PF. This innovative solution is specifically designed to assist biopharmaceutical manufacturers in seamlessly integrating Pre-Use Post-Sterilization Integrity Testing (PUPSIT) into their filtration processes, ensuring the highest product safety and quality standards.
The SciLog® NFF+ PF system addresses the complexities of implementing PUPSIT in biopharmaceutical manufacturing environments. This fully automated, multipurpose Normal Flow Filtration (NFF) system features an onboard PUPSIT solution. It is designed with a compact footprint, making it ideal for Good Manufacturing Practice (GMP) operating environments.
In response to the updated EU GMP Annex 1 guidelines, PUPSIT – an essential procedure for verifying the integrity of sterilizing filters before use – has become mandatory in most sterilizing filtration applications. This requirement is integral to quality risk management strategies aimed at validating filter integrity prior to its application.
However, implementing PUPSIT can introduce increased risks, such as a higher number of connections and elevated operating pressures, which can lead to human error and necessitate additional operator training. Operational errors can result in product waste, potentially affecting supply chains.
Parker has integrated single-use flow paths, advanced sensing technology, and automation within the SciLog® NFF+ PF system to mitigate these challenges. This design guides operators through the PUPSIT process and overall bioprocessing via an intuitive interface, significantly reducing the risk of human error. Operators can configure fully automated sequences to monitor, adjust, and record pressure and flow rates, optimizing processing times and maximizing filter life and efficiency. The system executes the sterile filtration sequence, with PUPSIT seamlessly integrating as a key step in the process, ensuring filter integrity is validated before product filtration.
